To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications
This research study is looking at a new drug called CVN424 for people living with Parkinson's disease. Specifically, it's for those who experience 'motor complications,' which means their Parkinson's symptoms (like stiffness or slow movement) get worse at certain times, often called 'OFF' periods. The study wants to find out how well CVN424 works to improve these 'OFF' times. Participants will be randomly assigned to take either one of two doses of CVN424 or a placebo (a dummy pill with no active medicine) once a day for 12 weeks. This is a blind study, meaning neither the participants nor their doctors will know who is getting the active drug and who is getting the placebo, to ensure fair and accurate results. There's also the possibility to join an extended study if this one goes well.
At a glance
What is this study about?
This study is about finding better ways to manage Parkinson's disease, especially for people who experience what are called 'motor complications.' If you have Parkinson's, you might notice that your medication works well for a while, but then its effects can wear off before your next dose, leading to periods where your movements become more difficult. These are often called 'OFF' times.
The new medicine being tested is called CVN424. Researchers want to see if CVN424 can help reduce these 'OFF' periods and make managing daily life with Parkinson's a bit easier. This is an important step in medical research, as it could potentially offer a new treatment option for many people.
To get the most accurate results, the study will compare CVN424 against a placebo. A placebo looks exactly like the study medicine but doesn't contain any active ingredients. This helps researchers understand whether any improvements seen are truly due to CVN424 or other factors. Participants will be carefully monitored throughout the study to track changes in their symptoms and overall well-being.
Key takeaways
- This study is testing a new medicine, CVN424, for people with Parkinson's and 'OFF' times.
- It aims to see if the medicine can reduce these periods when symptoms worsen.
- Participants will take either CVN424 or a dummy pill (placebo) for 12 weeks.
- Your regular Parkinson's medication will continue at a stable dose.
- Close monitoring and regular clinic visits are part of taking part.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, doctors will first check if it's the right fit for you. Generally, you need to have Parkinson's disease that has been officially diagnosed using specific medical guidelines. You also need to be experiencing those 'OFF' periods we talked about for a certain amount of time each day, and be able to clearly identify when you're 'ON' (medication working) or 'OFF' (medication wearing off). Your Parkinson's symptoms shouldn't be too advanced, and you should be able to walk, even if you use a walking aid.
It's important that you've been taking your current Parkinson's medications at a stable dose for at least a month, or longer for some specific medications. Your general health will also be checked, including your body weight. You'll need to have a good memory and thinking ability to follow the study instructions. There are also specific requirements for women who could become pregnant and men with female partners who could become pregnant, regarding contraception.
There are also some reasons why you might not be able to join. For example, if your Parkinson's diagnosis isn't typical, or if you have very severe or disabling uncontrolled movements (dyskinesias) or 'OFF' times that would make it too difficult to participate safely in the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a confirmed diagnosis of Parkinson's disease?
- Do I experience 'OFF' times lasting at least 3 hours a day?
- Am I taking my Parkinson's medications at a stable dose?
- Can I walk by myself, even if I use a walking aid?
- Am I able to understand and follow study instructions?
- Am I willing to use contraception if it applies to me?
What does participation involve?
If you decide to join this study, you would first go through a screening process to make sure you meet all the requirements. Once confirmed, you would be randomly assigned to one of three groups: receiving either a 75 mg dose of CVN424, a 150 mg dose of CVN424, or a placebo (a dummy pill). You would take your assigned medication once a day by mouth for 12 weeks.
Throughout these 12 weeks, you would have regular visits to the clinic so the study team can check on your health and how you're responding to the treatment. They will likely ask you to complete special diaries to track your 'ON' and 'OFF' times, assess your Parkinson's symptoms, and monitor for any side effects. You'll also have blood tests and other assessments. After the 12 weeks, if you successfully complete this part of the study and are still suitable, you might be invited to continue with the treatment in an 'open-label' extension study, where everyone would receive the active medication.
Potential risks and benefits
Locations (94)
- The Kirklin Clinic of UAB HospitalVerified postcodeBirmingham, United States
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- University of Alabama at Birmingham ALS ClinicVerified postcodeBirmingham, United States
- Barrow Neurological InstituteVerified postcodePhoenix, United States
- Muhammad Ali Parkinson CenterVerified postcodePhoenix, United States
- St. Joseph's Hospital and Medical CenterVerified postcodePhoenix, United States
- Parkinson's Research Centers of America - Orange countyVerified postcodeAliso Viejo, United States
- Parkinson's Research Centers of America - Orange CountyVerified postcodeNewport Beach, United States
- Parkinson's Research Centers of America - Palo AltoVerified postcodePalo Alto, United States
- CenExel Rocky Mountain Clinical ResearchVerified postcodeEnglewood, United States
- David and Rhoda Chase Family Movement Disorders Center - VernonVerified postcodeVernon, United States
- Parkinson's Disease and Movement Disorders Center of Boca RatonVerified postcodeBoca Raton, United States
Common questions
What are 'motor complications' or 'OFF' times?
These are times when your Parkinson's medication isn't working as well, and your symptoms like stiffness, slowness, or tremor become more noticeable and make daily activities harder.
What does 'randomised and double-blind' mean?
It means you're put into a treatment group by chance (randomised), and neither you nor your doctors will know if you're taking the active medicine or the dummy pill (double-blind) until the study finishes. This helps make the study fair.
Will I still take my regular Parkinson's medication?
Yes, you will continue your usual Parkinson's medications, and their doses need to be stable before you can join the study.
How long will I be in the study?
The main part of the study lasts 12 weeks, with follow-up appointments. There might be an option to join a longer study afterwards.
What is a 'placebo'?
A placebo is a pill that looks exactly like the study medicine but contains no active drug. It's used for comparison to see if the real medicine has an effect.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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